Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance - Full Text View

Sponsored by:	St. Luke's-Roosevelt Hospital Center
Information provided by:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT00264251

Purpose

The purpose of this study is to determine if, in men and women with excess abdominal fat and insulin resistance, people with HIV infection respond differently than people without HIV to interventions that typically improve body fat distribution and insulin resistance. The specific interventions are:

Diet + exercise program.
Rosiglitazone treatment.
A combination treatment of diet + exercise program and rosiglitazone.

Condition	Intervention
HIV Infections Insulin Resistance Obesity	Behavioral: Weight loss through diet and exercise Drug: Rosiglitazone insulin sensitizing agent

MedlinePlus related topics: AIDS Exercise and Physical Fitness Obesity Weight Control

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Diet, Exercise and Rosiglitazone on Regional Fat and Insulin Resistance in HIV-Infected and Uninfected Men and Women

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:

Insulin sensitivity
Body composition

Secondary Outcome Measures:

Quality of life
Strength and fitness
Lipid profile
Additional cardiovascular risk indicators

Estimated Enrollment:	48
Study Start Date:	July 2005
Study Completion Date:	August 2007

Detailed Description:

A constellation of nutritional alterations in HIV-infected patients receiving highly active antiretroviral therapies (HAART), including body fat redistribution with subcutaneous adipose tissue (SAT) wasting and visceral adipose tissue (VAT) accumulation, hyperlipidemia, and insulin resistance (IR) has been described. There is a major concern that these developments will be associated with adverse clinical outcomes related to atherosclerosis, as suggested by several case reports (Henry 1998, Behrens 1998, Gallet 1998, Vittecoq 1998). Although there are well documented associations among body fat distribution, insulin resistance, and adverse health outcomes, especially accelerated atherosclerosis, in non-HIV infected individuals, it is unclear if the relationships are affected by HIV infection, or if they reflect the same outcomes. This information is important, since understanding the interrelationships between body fat distribution and metabolism may guide the development of treatment strategies.

The specific hypotheses to be tested are:

HIV infection does not affect the relative reductions in visceral (VAT) and subcutaneous adipose tissue (SAT) resulting from diet + exercise, but decreases the effect of this therapy on insulin resistance.
HIV infection decreases the changes in insulin resistance and body composition (increase in SAT and decrease in VAT) expected with rosiglitazone.
The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a greater extent than rosiglitazone alone, and will improve insulin resistance to greater extent than diet and exercise alone, however these effects will be blunted in HIV-infected subjects.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

HIV-infected or uninfected.
Body mass index (BMI) at least 25.
Excess visceral adipose tissue. Excess VAT will be determined in HIV+ and HIV- groups of men by a waist hip ratio > 0.95 and a waist circumference >88.2 cm, and in women by a waist:hip >0.9 and waist circumference >75.3 cm.
Insulin resistance (fasting serum insulin level >16 μU/ml).

Exclusion Criteria:

Unable to tolerate magnetic resonance imaging (MRI)
Clinical evidence of active liver disease or a significantly abnormal liver function test (ALT >2.5x the upper limit of normal).
Severe hyperlipidemia (fasting plasma triglycerides >500 mg/dL or fasting total cholesterol >300mg/dL)
Current coronary artery disease including angina
Peripheral vascular disease
Uncontrolled hypertension
Participation in a regular exercise program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264251

Locations

United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

Principal Investigator:	Donald P Kotler, MD	St. Luke's-Roosevelt Hospital Center, Columbia University
Principal Investigator:	Jeanine B Albu, MD	St. Luke's-Roosevelt Hospital Center, Columbia University

More Information

Study ID Numbers:	SLRHC 02-117
Study First Received:	December 9, 2005
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00264251
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:

HIV
Body composition
Weight reduction
Insulin resistance/sensitivity

Exercise
Diet
Visceral adiposity

Study placed in the following topic categories:

Obesity
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Acquired Immunodeficiency Syndrome
Overweight
Insulin
Immunologic Deficiency Syndromes
Body Weight
Virus Diseases
Signs and Symptoms
Hyperinsulinism

HIV Infections
Weight Loss
Sexually Transmitted Diseases
Nutrition Disorders
Overnutrition
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Hypoglycemic Agents
Slow Virus Diseases
Immune System Diseases

Physiological Effects of Drugs
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009